Is the Director of Quality role remote?

It's hybrid — Ketryx expects some on-site time in Boston, Massachusetts, United States.

What's the salary range?

Ketryx lists $150,000–$185,000 for this role.

How much experience is required?

At least 10 years of relevant experience for this Director of Quality role.

Where is the role based?

Ketryx is hiring for this position in Boston, Massachusetts, United States.

What's the tech stack?

Joblaze extracted these technologies from the posting: AI governance, IEC 61508, IEC 62304, ISO 13485, ISO 14971, ISO 26262.

What seniority level is this role?

Ketryx targets director candidates for this position.

Is this full-time or contract?

Full-time for this Director of Quality role at Ketryx.

Director of Quality at Ketryx

Joblaze summary

The Director of Quality at Ketryx is responsible for overseeing the Quality Management System and Information Security Management System, ensuring that processes remain effective and compliant with industry standards. This role requires extensive experience in quality assurance within regulated sectors, particularly MedTech or BioPharma, along with a strong grasp of risk management and audit processes. Ideal candidates will have a proven track record in leading quality initiatives and communicating effectively across technical and non-technical teams. Ketryx emphasizes a collaborative environment, partnering with various departments to enhance compliance and quality in medical software.

Joblaze insights

Listed today — first seen on Joblaze October 23, 2026. Last confirmed on Ketryx's careers page October 23, 2026.
Salary band is below the typical range for Management roles (median ~$170,000).
Starts above 5% of 295 comparable director management roles in United States we track (median $200,000 across 125 companies).
SOC 2 appears in 1.1% of 542 comparable director management roles in United States; ISO 13485 appears in 0.2% of 542 comparable director management roles in United States.

Quick facts

Is the Director of Quality role remote?: It's hybrid — Ketryx expects some on-site time in Boston, Massachusetts, United States.
What's the salary range?: Ketryx lists $150,000–$185,000 for this role.
How much experience is required?: At least 10 years of relevant experience for this Director of Quality role.
Where is the role based?: Ketryx is hiring for this position in Boston, Massachusetts, United States.
What's the tech stack?: Joblaze extracted these technologies from the posting: AI governance, IEC 61508, IEC 62304, ISO 13485, ISO 14971, ISO 26262.
What seniority level is this role?: Ketryx targets director candidates for this position.
Is this full-time or contract?: Full-time for this Director of Quality role at Ketryx.

From the original posting

Job Title: Director of Quality
Employment Status: Full-time
Office Hours: Monday - Friday; hybrid schedule
Location: Boston, Massachusetts
Compensation: $150,000 - $185,000, plus equity options. (Compensation dependent on experience level)

The Director of Quality owns Ketryx's Quality Management System (QMS), Information Security Management System (ISMS), AI governance program, and certification portfolio. This leader keeps our processes effective, scalable, and audit-ready while helping the business ship and serve enterprise customers efficiently. Because Ketryx builds compliance software for regulated industries, the role is also an internal reference user of our platform and a public voice on quality and regulatory practice.

What You'll Do

Own the QMS and support the ISMS: Keep policies, SOPs, and records aligned with how we operate, including ISO/IEC 27001 and SOC 2 programs.
Lead AI governance: Own AI policies and ISO/IEC 42001 conformity, and set assurance expectations for validated AI agents.
Run audits and certifications: Lead readiness and execution for ISO 13485, IEC 62304, ISO 14971, ISO/IEC 27001, SOC 2, IEC 61508, and ISO 26262, plus customer audits and supplier assessments.
Govern change and release: Define risk-based gates and evidence expectations, and own release-level risk assessments.
Enable customers and deals: Maintain validation packages and the trust center, and support questionnaires, RFPs, and strategic accounts where compliance is a blocker.
Track regulation: Monitor emerging requirements (e.g., EU MDR, EU Cyber Resilience Act, 21 CFR Part 11) and translate them into internal and customer guidance.
Lead the QA/RA consulting team: Staff engagements, set deliverable standards, provide final review, and develop consultants.
Partner across the company: Work with Engineering, Product, Security, Sales, and leadership, and represent Ketryx externally through content, conferences, and standards work.

How Success Is Measured

Zero major nonconformities in certification audits, with findings closed on time
All committed certifications achieved or maintained, including ISO 26262 by August 2027
Validation packages and risk assessments published for every platform release
Fast, reliable responses to customer compliance inquiries and deal blockers
High-quality consulting deliverables with zero quality-related escalations

What We're Looking For

10+ years of experience in quality at a MedTech, BioPharma, or Life Sciences company
Track record operating or leading a QMS and supporting external audits in a regulated environment
Experience owning or materially supporting an ISMS under ISO/IEC 27001 or equivalent
Strong command of risk-based quality practices and change and release governance
Clear communicator with technical and non-technical audiences, with strong documentation skills

Nice to Have

Hands-on audit experience across ISO 13485, IEC 62304, ISO 14971, ISO/IEC 42001, IEC 61508, ISO 26262, and SOC 2
Experience with AI governance and validating AI-enabled features
Background supporting customer validation and security questionnaires for enterprise SaaS
Familiarity with functional safety tool qualification
Experience leading a team of quality or regulatory professionals

What We Offer

Standard company text repeated across Ketryx's postings is omitted here.